Clinical trial · Observational
Clinical and Dosimetric Study of Patients Treated With 177Lu-PSMA-617 for Prostate Cancer.
Optimisation and Safety of an Innovative Nuclear Medicine Treatment: Clinical and Dosimetric Study of Patients Treated With 177Lu-PSMA-617 for Prostate Cancer.
NCT06700057CI-TRIAL-00102100DOSIPROSTATErecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Single-centre, retrospective and prospective observational study. This study aims to evaluate the dose delivered by radiation to the tumour and organs at risk, as a factor predicting response and the appearance of toxicities. Dosimetric calculations are made for each treatment using scintigraphic images acquired following injection of 177Lu-PSMA-617.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastasis | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Median of total absorbed-dose of 177Lu-PSMA-617 at total tumor volume as a function of prostate-antigen specific (PSA) response
- timeFrame
- From pre-treatment baseline to the end of treatment and after the end of treatment, i.e approximately 10 months.
- description
- To assess the association between the total absorbed-dose of treatment at total tumor volume and the efficacy of treatment in terms of PSA response rate (PSA50-RR). PSA50-RR is defined by the proportion of patients with a decrease ≥ 50% in PSA concentration from pre-treatment baseline, confirmed by a subsequent PSA assessment performed at least 3 weeks later. Absorbed-dose of treatment at total tumor volume, expressed in Gray (Gy), is calculated for each course of 177Lu-PSMA-617 (every 6 weeks +/- 1 week) from SPECT/CT images acquired post administration with PlanetDose software (DOSIsoft). The total absorbed dose in Gray (Gy) is defined by the sum of absorbed doses over all courses of treatment performed.
Secondary outcomes (2)
- measure
- Median of total absorbed-dose of 177Lu-PSMA-617 at total tumor volume as a function of best overall response (RECIST v1.1)
- timeFrame
- From pre-treatment baseline to the end of treatment and after the end of treatment, i.e approximately 10 months.
- description
- To assess the association between the total absorbed-dose of treatment at total tumor volume and the efficacy of treatment in terms of best overall response according to RECIST v1.1. Best overall response is defined as the best response evaluated according to RECIST v1.1, observed between initiation and end of treatment. It is determined once all data for the same patient are known. Absorbed-dose of treatment at total tumor volume, expressed in Gray (Gy), is calculated for each course of 177Lu-PSMA-617 (every 6 weeks +/- 1 week) from SPECT/CT images acquired post administration with PlanetDose software (DOSIsoft). The total absorbed dose in Gray (Gy) is defined by the sum of absorbed doses over all courses of treatment performed.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient aged 18 and over. 2. Patient with indication for or having started or completed treatment with 177Lu-PSMA-617 since 01/11/2023: 1. Progressive, metastatic, castration-resistant prostate cancer, 2. overexpressing prostate specific membrane antigen (PSMA) 3. treated with taxane chemotherapy and at least one 2nd generation hormone therapy (apalutamide, enzalutamide, darolutamide, abiraterone-prednisone). 3. Patient able to lie still for 1 hour for image acquisition. 4. Patient's place of residence \< 2 hours' drive from the Institut Bergonié. 5. Patient has not expressed any opposition to the use of his/her medical data for research purposes. Exclusion Criteria: None
References
Publications (0)
Data not yet available
No reference posted for this study.